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Completed

NCT Number: NCT04530968

Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness

Following severe traumatic brain injury, patients may remain unconscious for many years. It is the intestinal microbiome and metabolomics analysis comparing differentially intestinal microflora and metabolites between patients with chronic disorder of consciousness and controls so far. The investigators have mature data analysis technology. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness

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Key information

Conditions

Disorder of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SCIEX QTRAP 5500 liquid chromatograph / triple quadrupole mass spectrometer.

Hangzhou, Zhejiang, 310002, China

About this study

Objective:To determine differences in metabolic profiles and Intestinal microbial abundance among healthy human individuals and patients in a vegetative state (VS) and minimally conscious state (MCS) and to identify metabolites in human plasma that can accurately distinguish VS patients from MCS patients.

Method: Plasma samples and fecal sample were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A comprehensive metabolic profile was obtained with targeted metabolomics analysis and untargeted and targeted lipidomics analysis, as well as intestinal microbial abundance from 16S rRNA gene amplicon sequencing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ages 18 to 80 years old;
  • Patients had a history of severe Traumatic brain injury (TBI);
  • Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
  • Patients stay unconscious for more than 1 month.

Exclusion criteria

  • Patients with disorders of consciousness caused by other inducements;
  • Other neurological or psychiatric conditions prior to the current brain injury;
  • Persistent seizure-like activity, inhibition or seizure inhibition;
  • The patients had taken a sedative barbiturate neuroleptics or antidepressants within one month;
  • The clinical state is unstable, and there are signs of spontaneous recovery or deterioration within 1 week;
  • The patients have taken gastrointestinal motility drugs or other drugs affecting gastrointestinal motility in the past month;
  • Had taken antibiotics and probiotics in the past month;
  • Patients with intestinal diseases such as colon cancer, ulcerative colitis or crohn's disease;
  • Patients with acute infectious diseases or liver dysfunction

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. metabolic profiling and Intestinal microbial spectrum

    Time frame: 1 month

    A comprehensive metabolic profile from plasma was obtained with targeted metabolomics analysis and untargeted and targeted lipidomics analysis; intestinal microbial spectrum was obetained from fecal by16S rRNA gene sequencing among HCs, EMCS, MCS and VS groups.

Secondary outcomes

  1. Coma Recovery Scale-Revised(CRS-R)

    Time frame: 30 minutes before samples collection

    Coma Recovery Scale-Revised (CRS-R) score was used to quantify the severity, which consists of 23 hierarchically arranged items that comprise six subscales addressing auditory, visual, motor, oromotor/verbal, communication, and arousal processes. The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors In total, The lowest mark on the scale is 0 and the highest mark is 23. To a certain extent, the higher the score is, the better the level of consciousness is, whereas the lower the level of consciousness is.

  2. Glasgow Outcome Scale (GOS)

    Time frame: 6 months

    A GOS value of <3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery.

  3. Indicators of brain connectivity by EEG

    Time frame: On the same day as collecting the samples

    Phase locking value (PLV)

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Aug 28, 2020
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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